DiabetesPhase 2/3HODiVANCT01002209
Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery
A Phase 2/3 study testing Hyperbaric Oxygen treatment (HBO) in people with Diabetes and Peripheral Arterial Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is effective in reducing healing time and wound complications after lower extremity bypass surgery in patients with diabetes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Peripheral Arterial Disease, Arterial Occlusive Disease
- What is being tested?
- Hyperbaric Oxygen treatment (HBO)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2019to Oct 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients are eligible for inclusion if the following criteria are fulfilled
- Informed consent obtained
- Scheduled for lower extremity open vascular surgery
- Diabetes treated with insulin or oral antidiabetic medicine
- Age ≥ 18 years
Who cannot join
- Contraindications to HBO therapy
- Pregnancy (women of childbearing potential will undergo pregnancy test before inclusion)
- Patients already in HBO treatment
- Vascular reoperation
- Creatinine > 250 mmol/L
- NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber
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- Clinically significant chronic obstructive pulmonary disease.
- Acute sepsis.
- Malignancy or other serious medical condition where it is likely that the patient will significantly deteriorate or not survive within the two years of follow up.
- Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices.
- Mental condition making the subject unable to understand the concepts and risk of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery (HODiVA) - A Double Blind, Randomized Controlled Study
This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is effective in reducing healing time and wound complications after lower extremity bypass surgery in patients with diabetes.
Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients with diabetes undergoing peripheral vascular surgery
- Being tested
- Hyperbaric Oxygen treatment (HBO), Sham HBO
- Keywords
- Diabetes, Vascular Surgery, Hyperbaric oxygen, Surgical complications, Wound complication, Randomized, Controlled
- Medical subject headings
- Diabetes Mellitus, Peripheral Arterial Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen treatment (HBO)Procedure or surgery
HBO treatment will be given in a monoplace chamber and will start on first postoperative day (study day 1). The HBO group will be treated with 100% oxygen at 2.5 bar for 100 min with two 10 min airbrakes (without mask).
HBO treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO/placebo treatment and who have a clearly uncomplicated postoperative course will terminate HBO/placebo treatment on the day of discharge from hospital.
Sham HBOProcedure or surgery
HBO sham treatment will start on first postoperative day (study day 1). HBO sham treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO sham treatments and who have a clearly uncomplicated postoperative course will terminate HBO sham treatment on the day of discharge from hospital.
For patient blinding purposes, the sham group will breathe air and will be given a brief compression to 1.5 bar at the beginning of each treatment after which the chamber is slowly decompressed to 1.1, 1.2 , 1.3, or 1.4 bar corresponding to 0.23 ,0.25, 0.27, and 0.29 bar inspired oxygen. Two 10 min "airbrakes" will also be included.
| Study group | Role | What they receive |
|---|---|---|
| Sham Hyperbaric Oxygen Treatment | Sham comparator | Not described Receives: Procedure: Sham HBO |
| Hyperbaric oxygen treatment (HBO) | Experimental | Not described Receives: Procedure: Hyperbaric Oxygen treatment (HBO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete healing of operative wounds
Measured: 7-365 days
Secondary outcomes (8)
Number of wound infections at 7 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.
Measured: 7 days (plus minus 3 days)
Number of wound infections at 30 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.
Measured: 30 days (plus minus 3 days)
The severity of wound infection defined as by ASEPSIS score: 0-10= satisfactory healing 11-20= disturbed healing 21-30= minor wound infection 31-40= moderate wound infection >40= severe wound infection.
Measured: highest score up to 30 days (plus minus 3 days)
A combination of any wound infection and/or unhealed wounds at 30 days (combined endpoint).
Measured: 30 days (plus minus 3 days)
SF-36 score
Measured: 7, 14, 28, 365 days (plus minus 3 days)
Major amputation or death. This will be assessed as "amputation-free survival". A major amputation is defined as any ipsilateral amputation through or above the ankle.
Measured: 0-365 days
Tissue perfusion and oxygenation on dorsum of foot on operated extremity as assessed by Transcutaneous oximetry during normobaric air breathing and after 6 min normobaric 100% oxygen challenge
Measured: day 3-5, 7 and 14, 28, 365 (plus minus 3 days)
HBO complications (confinement anxiety, barotrauma, oxygen convulsions)
Measured: During HBO treatment up to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startOct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Changes in the organisation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerstin Brismar, Professor, Study director, Karolinska InstitutetJonas Malmstedt, MD, Principal investigator, Karolinska InstitutetFolke G Lind, MD, PhD, Principal investigator, Karolinska InstitutetSergiu Catrina, MD, PhD, Principal investigator, Karolinska InstitutetJoy Roy, MD, PhD, Principal investigator, Karolinska InstitutetNils Pettersson, MD, PhD, Principal investigator, Karolinska InstitutetBengt M Eriksson, MD, Principal investigator, Hyperbaric Medicine, Karolinska Univ Hosp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002209
- Sponsor's protocol ID
- HODIVA
- Acronym
- HODiVA
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2009
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery (HODiVA) - A Double Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01002209
- Acronym / sponsor ID
- HODiVA / HODIVA
- Keywords
- Diabetes, Vascular Surgery, Hyperbaric oxygen, Surgical complications, Wound complication, Randomized, Controlled
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in the organisation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is effective in reducing healing time and wound complications after lower extremity bypass surgery in patients with diabetes.
Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients with diabetes undergoing peripheral vascular surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Hyperbaric Oxygen Treatment | Sham comparator | Procedure: Sham HBO |
| Hyperbaric oxygen treatment (HBO) | Experimental | Procedure: Hyperbaric Oxygen treatment (HBO) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are eligible for inclusion if the following criteria are fulfilled
- Informed consent obtained
- Scheduled for lower extremity open vascular surgery
- Diabetes treated with insulin or oral antidiabetic medicine
- Age ≥ 18 years
Key exclusion criteria (11 listed)
- Contraindications to HBO therapy
- Pregnancy (women of childbearing potential will undergo pregnancy test before inclusion)
- Patients already in HBO treatment
- Vascular reoperation
- Creatinine > 250 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen treatment (HBO)HBO treatment will be given in a monoplace chamber and will start on first postoperative day (study day 1). The HBO group will be treated with 100% oxygen at 2.5 bar for 100 min with two 10 min airbrakes (without mask). HBO treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO/placebo treatment and who have a clearly uncomplicated postoperative course will terminate HBO/placebo treatment on the day of discharge from hospital. | Procedure or surgery | Hyperbaric oxygen treatment (HBO) |
| Sham HBOHBO sham treatment will start on first postoperative day (study day 1). HBO sham treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO sham treatments and who have a clearly uncomplicated postoperative course will terminate HBO sham treatment on the day of discharge from hospital. For patient blinding purposes, the sham group will breathe air and will be given a brief compression to 1.5 bar at the beginning of each treatment after which the chamber is slowly decompressed to 1.1, 1.2 , 1.3, or 1.4 bar corresponding to 0.23 ,0.25, 0.27, and 0.29 bar inspired oxygen. Two 10 min "airbrakes" will also be included. | Procedure or surgery | Sham Hyperbaric Oxygen Treatment |
Primary outcome
Time to complete healing of operative wounds
Time frame: 7-365 days
8 secondary outcomes
Number of wound infections at 7 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.
Time frame: 7 days (plus minus 3 days)
Number of wound infections at 30 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.
Time frame: 30 days (plus minus 3 days)
The severity of wound infection defined as by ASEPSIS score: 0-10= satisfactory healing 11-20= disturbed healing 21-30= minor wound infection 31-40= moderate wound infection >40= severe wound infection.
Time frame: highest score up to 30 days (plus minus 3 days)
A combination of any wound infection and/or unhealed wounds at 30 days (combined endpoint).
Time frame: 30 days (plus minus 3 days)
SF-36 score
Time frame: 7, 14, 28, 365 days (plus minus 3 days)
Major amputation or death. This will be assessed as "amputation-free survival". A major amputation is defined as any ipsilateral amputation through or above the ankle.
Time frame: 0-365 days
Tissue perfusion and oxygenation on dorsum of foot on operated extremity as assessed by Transcutaneous oximetry during normobaric air breathing and after 6 min normobaric 100% oxygen challenge
Time frame: day 3-5, 7 and 14, 28, 365 (plus minus 3 days)
HBO complications (confinement anxiety, barotrauma, oxygen convulsions)
Time frame: During HBO treatment up to day 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerstin Brismar, Professor study director
Karolinska Institutet
Jonas Malmstedt, MD principal investigator
Karolinska Institutet
Folke G Lind, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyperbaric Oxygen treatment (HBO) in people with Diabetes and Peripheral Arterial Disease, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete healing of operative wounds (time frame: 7-365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.